inforMED
MalfunctionFII

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Received Dec 12, 2009 · Event occurred Oct 10, 2009

Report 1562239 · MDR key 1562239

Device

Generic name

Hemodialysis Machine, Continuous Renal Replacement Therapy

Model number

PRISMAFLEX

Catalog number

*

Lot number

*

Product problems

  • Device Displays Incorrect Message

Patient

64 YR

  • No Information

Narrative

Description of Event or Problem

CONTINUAL ALARMS ON CONTINUOUS RENAL REPLACMENT THERAPY (CRRT) MACHINE FOR "ACCESS EXTREMELY NEGATIVE" FOR LAST 24 HOURS (OR MORE). THERE WERE FREQUENT RESET-UPS AND RECIRCING DONE. RENAL FELLOW AWARE AND WAS CONSIDERING NEW DEVICE. UPON ARRIVAL THIS AM, I ATTEMPTED TO TROUBLESHOOT THE FILTER. I CLAMPED THE ARTERIAL ACCESS AND USED 0.9 NORMAL SALINE FLUSH WIDE OPEN AS ARTERIAL SOURCE. HOWEVER, THE MACHINE CONTINUED TO HAVE "ACCESS EXTREMELY NEGATIVE" ALARM. CONTINUED TO RUN BY PUSHING CONTINUE MULTIPLE TIMES, AND WAS ABLE TO GIVE HIM MOST OF HIS BLOOD BACK. NO LARGE CLOTS SEEN IN THE SYSTEM. DIALYSIS RN CALLED TO LOOK AT MACHINE. SET UP AND MACHINE SAVED, AND LEFT ON. BIOMED CALLED AND WAS ADVISED TO TURN OFF MACHINE, DISPOSE OF SET UP, PUT TAG ON MACHINE, AND PUT IN BACK ROOM. NEW CRRT MACHINE TO BE USED.